Reported Aug 5, 2015 · Terminated

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA,…

Mutual Pharmaceutical Company, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mutual Pharmaceutical Company, Inc. · 1100 Orthodox St · Philadelphia, PA · 19124-3168

Is this the product you have?

  • Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
Lot codes and dates
    • Lot #: 6676701 and 6676801
    • exp 1/17
Amount recalled
20,892 bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 13, 2016 · Data as of Sep 19, 6:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.